1. Field of the Invention
The present invention relates to packaging devices for surgical elements, and more particularly to breather pouches for enclosing surgical suture-needle packages.
2. Discussion of the Prior Art
Breather packages for packaging surgical elements in which a sheet of clear plastic is adhered to a paper, cardboard or other fibrous material backing to provide a sterile display environment for the surgical device are well known in the art. These breather packages generally enclose a sterilized package of surgical devices or elements, such as needles or suture-needle assemblies. The surgical package is fit between the fibrous material backing and the plastic layer and the plastic is then sealed to the fibrous layer to completely enclose the surgical package.
However, while the assembly process of such a package generally provides a secure package which is aesthetically pleasing as a final end product display package, several distinct problems occur upon opening the package, particularly within the sterile environment of an operating room. One of the more popular packaging materials for use in the surgical suture and surgical instrument field is a material known as Tyvek (a registered trademark of DuPont), which is a fibrous material constructed of spunbonded polyolefin, in which the polyolefin fibers are spun into a web and compressed to form a high strength porous material. It is common to use Tyvek as the backing material for the breather pouch, whereby the outer layer of plastic material is heat sealed to the edges of the Tyvek sheet to secure the suture package therebetween.
A distinct disadvantage concerning packages formed in this manner, as well as any package including a fibrous material such as Tyvek, cardboard, fiberboard, paper or the like, lies in the fact that when the plastic layer is adhered to the fibrous layer, whether by means of adhesives, heat seals or any other method, upon removing the plastic layer from the fibrous layer there is a tendency for the fibrous layer to separate from itself so that the fibers pull apart from each other. This occurrence, known as "fiber-pull", is similar to a delamination of the layers and occurs at the edges of the fibrous layer where the ends of the fibers are exposed. As the plastic layer is peeled back for removal from the fibrous layer, fiber-pull generally occurs at the edges and results in the continued encapsulation of the package disposed within the breather pouch.
This occurrence of fiber-pull can create two problems in an operating room during surgery. The most important problem is the fact that upon pulling the plastic layer from the fiber layer, if the suture package is still encapsulated in the breather pouch, it requires the surgical team member to further attempt to open the package which may result in a critical delay which may affect the health of the patient. Furthermore, in order to open such a package after the fiber layer has been removed, a sharp instrument may sometimes be necessary to puncture the pouch to get at the package inside. This will require the use of an instrument which has previously been sterilized, and whose sterility may be compromised in order to open the package.
A second problem resulting from the occurrence of fiber-pull is the fact that a large amount of clutter would result in the operating room if a significant number of sutures are required. Again, since the operating room is a sterile environment, the presence of a large number of torn pieces of fibrous paper, as well as particulate fibers which separate from the Tyvek, will be a detriment to the sterile conditions which are required.
In order to overcome the fiber-pull problem, in the prior art there are packages having a Tyvek layer adhered to a plastic layer through the provision of a release agent which is applied to the surface of the Tyvek layer which faces the plastic layer. The entire surface of the Tyvek material is coated with the release agent, which provides for a pull force to separate the plastic from the Tyvek which is lower than the pull force required to separate the fibers from themselves in the Tyvek layer. In general, after the release agent is applied to the Tyvek layer, the surgical suture package is positioned on the Tyvek and then the plastic layer is heat sealed through the release agent to the Tyvek about the periphery of the package.
This construction, while reducing the possibility of fiber-pull and its associated encapsulation problems, also suffers several disadvantages. A significant disadvantage is the increased cost required to produce the breather pouch, since an extensive amount of release agent material is used to cover the entire surface of the Tyvek layer. These release agents generally comprise adhesive materials which adhere to the Tyvek layer and dry to a nontacky finish.
A second important disadvantage lies in the fact that the application of the release agent to the entire surface of the Tyvek significantly reduces the amount of force necessary to separate the plastic layer from the Tyvek layer. As the plastic layer is peeled back from the Tyvek layer, if too much force is applied the plastic layer completely separates from the Tyvek layer resulting in the possibility that the suture package enclosed therein will fall to the floor. In any event, the complete separation of the plastic layer from the Tyvek layer results in two items to be discarded instead of one, and increases the amount of clutter in the operating room.
A further disadvantage concerns sterilization of the surgical elements packaged within the breather pouch. In general, after the pouch is sealed, the pouch is subjected to a sterilizing gas which passes through the fibrous Tyvek layer. In the prior art, the pouches having adhesive material coating the entire surface of the Tyvek suffer decreased porosity, and accordingly, require longer sterilization times.
A final significant disadvantage lies in the fact that the surgical element may adhere to the adhesive coating during storage, due to storage pressures and temperatures resulting from stacking on shelves or in warehouses. In addition, if the temperatures are too high during the heat sealing process, the surgical element may adhere to the Tyvek layer.
The novel breather pouch for surgical element packages such as sutures and suture-needle assemblies of the present invention obviates the disadvantages encountered in the prior art and provides a breather pouch which substantially reduces or eliminates fiber-pull associated with the prior art. The breather pouch of the present invention overcomes the fiber-pull problem without unduly increasing the cost of the package and further provides a pouch which separates easily to reveal the package enclosed therein without completely separating the plastic layer from the fibrous layer to reduce the amount of clutter in an operating room.